Trying to Keep Up in May

Regulatory StrategyClinical ResearchMedTech InsightsTrying to Keep Up
Written By Crystal Norwood

AI kept accelerating. FDA kept shifting. Everyone kept trying to keep up.

May’s TTKU episodes felt like a running conversation about what happens when regulation, AI, reimbursement, and real-world implementation all collide at once.

Across four episodes, Allison Komiyama and Michael Nilo were joined by regulatory leaders, former FDA reviewers, and industry experts to unpack some of the biggest questions facing MedTech right now:

  • How is FDA actually handling AI-enabled devices?

  • What happens when CMS enters the conversation earlier?

  • Are PCCPs finally becoming real?

  • Is real-world evidence actually usable yet?

  • And how many neurosurgical patties should one hospital really keep on hand?

As usual, the conversations covered serious regulatory and clinical topics, mixed with side tangents, terrible jokes, and occasional existential commentary about the state of healthcare innovation.

Watch May Episodes

Episode Highlights

AI is no longer hypothetical. The infrastructure questions are here now.

May’s conversations repeatedly circled back to AI-enabled medical devices — not as future concepts, but as products already reaching FDA review, authorization, and commercialization.

We discussed:

  • AI diagnostics and imaging systems

  • Digital pathology

  • Brain-computer interfaces

  • AI-enabled cardiovascular monitoring

  • FDA’s HALO and ELSA AI initiatives

  • The growing role of Predetermined Change Control Plans (PCCPs)

One recurring theme: FDA seems increasingly comfortable evaluating AI systems technically, but companies still struggle operationally with implementation, validation strategy, and lifecycle management.

We know how to regulate software. The question is how companies operationalize continuous learning and change. That tension showed up repeatedly throughout the month.

FDA consistency and staffing stayed front and center.

Leadership turnover, reviewer shortages, surprise inspections, and evolving initiatives all became major talking points.

We discussed:

  • FDA Commissioner turnover and agency leadership changes

  • One-day inspection pilots

  • International surprise inspections

  • Reviewer staffing challenges

  • Expanded hiring efforts

  • Ongoing uncertainty around TAP and RAPID

Several guests reflected on the realities inside FDA during periods of organizational change. There’s optimism, but there’s also a very real resource problem.

At the same time, former reviewers repeatedly emphasized that many FDA staff remain deeply mission-driven and committed to helping companies navigate difficult decisions despite operational instability.

Real-world evidence still sounds easier than it is.

Real-world evidence (RWE) was one of the biggest recurring themes of the month.

We unpacked:

  • FDA’s growing emphasis on RWE

  • MDIC and NEST initiatives

  • Data quality challenges

  • Patient-focused development

  • Registry data limitations

  • The gap between “real-world” and “regulatory-grade” evidence

The conversations highlighted a central challenge: FDA wants broader use of RWE, but companies still face uncertainty around what data is actually sufficient for decision-making.

FDA wants RWE, but also wants traceability, consistency, and validation that often turns it into a clinical study anyway.

There was excitement around where things are headed, but also realism about how much infrastructure still needs to evolve.

The patient experience matters more than ever.

Several discussions moved beyond pure regulatory mechanics and focused on what device development actually means for patients.

Topics included:

  • Home-based diagnostics

  • Reusable catheter systems

  • PTSD neurotechnology

  • Pediatric innovation

  • Patient preference information

  • Brain-computer interfaces (BCIs) for paralysis

  • AI mental health risks

Guests repeatedly emphasized that successful innovation requires understanding the full patient journey, not just endpoints or submission strategy.

That perspective came through especially strongly in discussions around:

  • Precision Neuroscience’s BCI platform

  • Home HPV screening

  • Neuromodulation technologies

  • AI-enabled behavioral health tools

FDA and CMS alignment is still evolving.

RAPID generated a lot of discussion throughout May.

The conversations explored:

  • Earlier CMS involvement in clinical strategy

  • Reimbursement-driven trial design

  • Parallel review concepts

  • Potential benefits and operational uncertainty

  • The future of TAP and RAPID eligibility

The overall takeaway: Better FDA/CMS coordination could dramatically improve patient access, but the mechanics still need work.

There’s excitement around the concept. The implementation questions are where things get complicated.

Why It Matters

May reinforced something that’s becoming increasingly clear across MedTech: The challenge is no longer just generating evidence. It’s navigating systems that are evolving in real time.

AI oversight is changing. FDA/CMS coordination is changing. Clinical evidence expectations are changing. Review infrastructure is changing.

The teams that succeed won’t necessarily be the ones with the biggest datasets or the flashiest technology.

They’ll be the ones that:

  • Stay adaptable

  • Build strong regulatory strategy early

  • Understand operational realities

  • Communicate clearly

  • Keep patients at the center of development

That’s what TTKU keeps coming back to every week.

May’s Jokes

  • Have you heard about the yardstick company? → They’re not making them any longer.

  • Why did the doctor carry a red pen? → In case he needed to draw blood.

  • Did you hear about the mansplainer who died in a puddle? → It was a well, actually.

  • What do regulatory and camping have in common? → They’re both intense/in tents.

  • Why are urologists great at fixing Netflix accounts? → They can get anything streaming.

  • What happens when a bronchoscope runs into a laparoscope? → A kaleidoscope.

  • Did you know Yoda had a last name? → Layheehoo

  • What’s a regulatory affairs horror story? → “Please clarify.”

  • Did you hear about the AI company that blamed its chatbot for noncompliance? → FDA did too.

Links

If you want to dig deeper, here’s what came up in May episodes:

FDA News & Updates

New De Novos

New PMAs

New Breakthrough Device Designations

  • Valar Labs’ Vesta Bladder Risk Stratify Dx: an AI-powered digital pathology prognostic test for bladder cancer, designed to analyze routine H&E pathology slides and help risk-stratify non-muscle-invasive bladder cancer patients

  • Gene Solutions’ SPOT-MAS 10: a multi-omics blood test designed to detect cancer-associated signals across 10 common and aggressive cancers

Trying to keep up with regulatory & clinical changes?

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Crystal Norwood
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What Happens After Clinical Trial Close-Out: Transitioning to Reimbursement